FDA UDI
In Commercial Distribution
🇺🇸 United States
Transystem™
DI: 28053326000595
·
Model: 110C.USE
·
COPAN ITALIA SPA
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
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Basic Information
- Brand Name
- Transystem™
- Primary DI
- 28053326000595
- Version / Model
- 110C.USE
- Catalog Number
- 110C.USE
- Company Name
- COPAN ITALIA SPA
- Labeler DUNS
- 428981112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 2
- Public Version Date
- 2023-04-28
- Public Version Status
- Update
- Public Device Record Key
- 5a7a5cb2-ce8c-4f5c-8e5a-bd266f00ed37
Device Description
TRANSYSTEM AMIES W/O CH ALUMINIUM APPLICATOR RAYON TIPPED
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSL | Culture Media, Anaerobic Transport | Microbiology | 866.2390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65196 | General specimen collection kit | A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38053326000592 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 28053326000595 | GS1 | ||||
| Unit of Use | 18053326000598 | GS1 | ||||
| Package | 68053326000593 | GS1 | 8 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972448 | 000 |